IRVINE, CA--(Marketwire - July 02, 2012) - Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that it has received a conditional Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to initiate the TRANSFORM Trial, a prospective, multi-center study that will evaluate the EDWARDS INTUITY valve system.
The TRANSFORM Trial is the first U.S. clinical trial of a rapid deployment system for surgical aortic valve replacement (AVR) procedures. The EDWARDS INTUITY valve system, which consists of a bovine pericardial heart valve and novel balloon-expandable frame, is designed to facilitate small incision surgery and rapid valve deployment with the goal of enabling faster procedures.
"This new valve platform is designed to provide a number of patient benefits, and we look forward to learning how a smaller incision and more rapid valve implantation may result in reduced operative time and improved patient outcomes," said Glenn Barnhart, MD, executive director and chief, Cardiac Surgical Services at Swedish Heart and Vascular Institute in Seattle, Washington. Dr. Barnhart provides paid educational consulting services to Edwards for heart valve technologies and training.
The TRANSFORM Trial will study the safety and effectiveness of the EDWARDS INTUITY valve system in a single arm study that will follow standard heart valve guidance and use historical controls. Heart valve trials typically enroll 500-700 patients.
"The EDWARDS INTUITY valve system is based on the design of our proven market-leading surgical valves, and includes a novel delivery system designed to enhance control, accuracy and simplicity throughout the implantation," said Donald E. Bobo, Jr., corporate vice president, heart valve therapy. "This innovative platform was developed with key insights from leading surgeons who share our commitment to the continued advancement of therapeutic options for their patients."
The EDWARDS INTUITY valve system is an investigational device not yet available commercially in the United States.
About Edwards Lifesciences
Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring that enable them to save and enhance lives. Additional company information can be found at www.edwards.com.
This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements include, but are not limited to, statements by Dr. Barnhart and Mr. Bobo, and statements regarding the timing and potential outcomes of the TRANSFORM Trial. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement.
Forward-looking statements involve risks and uncertainties that could cause the start date of the trial to differ materially from those expressed or implied by the forward-looking statements based on a number of factors including but not limited to unexpected changes or delays related to product supply and availability, patient enrollment or regulatory approval, or unexpected results of expanded clinical experience. These factors are detailed in the company's filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2011.
Edwards, Edwards Lifesciences, the stylized E logo, EDWARDS INTUITY and TRANSFORM and are trademarks of Edwards Lifesciences Corporation.